BEUDAMED
    FDA Adverse Event Other Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCU

    MDR report key: 1448933 · Received August 19, 2009

    Report

    Report Number
    2023826-2009-00923
    Event Type
    Other
    Date Received
    August 19, 2009
    Date of Event
    July 27, 2009
    Report Date
    July 27, 2009
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). LENS WORK ORDER SEARCH. RESULTS - A LENS WORK ORDER SEARCH WAS PERFORMED AND ONE SIMILAR COMPLAINT WAS FOUND WITHIN THE WORK ORDER. (B) (4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER SINGLE PIECE LENS AND THE LENS TORE. THE LENS WAS REMOVED WITH NO PATIENT INJURY. ANOTHER SAME MODEL LENS WAS IMPLANTED THE REPORTED STATED THEY FELT THE EVENT WAS DUE TO TECHNIQUE IN LOADING THE LENS. THE LENS WAS DISCARDED BY THE FACILITY. THIS IS ONE OF TWO LENSES USED ON THE PATIENT -SEE MFR REPORT #2023826-2009-00922.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCU INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR INJECTOR MODEL MSI-PF, LOT #UNK| FOAM TIP PLUNGER LOT #UNK| CARTRIDGE MODEL SFC-45 FP, LOT #UNK